~NEW FILE Drew or ore —— muLEvaRD F. J. L. Brastwcamer, M.D. executive vice president American Medical Association 535 NORTH DEARBORN STREET + CHICAGO 10, ILLINOIS Eanzst B. Howarn, M.D. esnstant executive vice president AREA CODE 312 327-1500 December 16, 1065 William H. Stewart, M.D, Surgeon General Public Health Service 330 Independence Ave., 8. W. Washington, D.C. Dear Doctor Stewarts The following comments concerning the proposed regulations implementing Public Law 80-239, the Heart Disease, Cancer and Stroke Amendments of 1965, are submitted to you in response to the invitation extended to the participants at your meeting held on December @, 1965, _ As you know, the American Medical Association bas a very deep interest in this new program. We are therefore very pleased to have the opportunity to comment upon the proposed regulations, At the outset, we should like to make the general observation that the proposed regulations are apparently not intended as being com- plete regulations at this time. We can appreciate that from time to ‘time, regulations must be amended and amplified, However, it would appear that these regulations, insofar as it is possible, should provide — a complete implementation of the Act, so that potential participanta and others may see this program in its full expectation. We should also like to direct your attention to a matter we dcem to be of significant importance. We note that part of the Act con- tained in Section 901(c) which provides that the funds oppropriated shall not be available to pay the cost of hocpital, medical, or other care of patients, execpt to the extent it is, aa determined in accordance with regulations, incident to those research, training, or demonstration activities which are encompassed by the purposes of this title (the pure poses herein referred to being those recited in Scction 900), Under Section 900 the demonstrations of patient care must be related to rescarch and training (including continuing education), ‘ YQ: Willtam H, Stewart, M.D. ~2- . December 16, 1965 In our review of the proposed regulations, we do not find _ reguintions as contemplated under Section 901(c). We believe that it is important that the intentions under this gection should be spelled out. As the Meport of the Committee on Interstate and Foreign Comraerce states (p. 10): "Ag introduced, the bill prohibited the use of appropri- ated funds to pay for the care of patients except te the extent that such care was incident to rescarch, training, or demonstration activities. | A clarifying amendment has been adopted which requires that the research, training, and demonstration activities rcforred to be those encompasaed by the reported bill." The Report contains the further statement (p. 11): "The committee wishes to emphasize that this legis- lation is intended to be administered in such @ way az to make no change whatsoever in the traditional methods of furnishing medical care to patients in the United States, or toe methods of financing guch care. " We believe that the intent of Congress is clear that patient care ie limited as being "incident" ta research and training activities. We also believe that this intent should be clearly pronounced in regula- tions. Qur comments to the sections of the proposed regulations, in the order in which they appear, follow. Additions which we believe nhould be made are indicated by underscored matter. ; (1) Section 66.3 - Definitions. Subsection (d), defining “related diseases, should be amendod by inserting the words and established after the word "direct, " so that the phrase will read, “bear a direct and established relationship," ete. We believe that this additional term carries the requirement that the related diseane have a medically recognized relation to the primary discase, and that this was the intend- ment of Congress. {3} Section 66.3 - Definitlons. In subsection (p), “prac- tieing physician" is dofined. Under the term "prac« ticing physician, " as defined in the reguietions, all that is required is licensure by the applicable state. We believe that thia sole criterion giver no effect to the word "practicing" and is therefore not in keeping with the Congressional intent. Accordingly, we recommend that the period after the word “laws" be William H. Stawart, M.D. =~ December 16, 1965 (3) (4) (5) (6) changed to a comms, and that the following phrase be added: , and who is primarily eneared in the diamosis and trontreent of paticnts. Ht ia our opinion that Concreas intended active praciitioners to be racmbera of the advis- ory group and the National Advisory Council, Section 66,3 © Definitions. We bcHeve that the word "demonstrations" should be defined to emphasize the intendment of this legislation concerning such demon« strations. An additional definition under Section 66.3 should be added as follows: (j) "Nemonstrations” meang an activity the purpone of which js the education of physicians and other health personnel, The inclusion ‘of this definition would reaffirm the intent of the Act as to the scope of the demonstrations, that is, that they must be related to rescarch and training (including continulng education). The dumonstration of patient eare must be only that which is "incident" to research and training (inclading continuing education). Section 68.3 Dofinitiong. We algo suggest that the following definition be added to Section 66.3: (i "Regional" gholl relate to a minimal scographical area possossing Bll of the componcnis necesrary for carrying out the purposes of Title TX, Section 86.4 « Eligibility. We believe that it would be helpful to the applicant to have "auch other criteria" as the Surgeon General may establish, set out as fully as possible in these regulations, 6o that the organizations now plomiing programs under this law know aa fully ag possible the criteria which they must meet. Section 63.8 « Application. Insert in subsection (¢), : in the second line after the word "shall," the numeral 44); change the period at the end of the sentence to a semicolon and insert the following phrase after the semicolon 3 end (2} with respect ta an apolication for grant under Section 204, chow cyidence that the propoucd progrem has been anproved by the advisory gxoup provided for in Section 003(p)(4), William A, Stewart, M.D, o4= December 16, 1985 (7) (8) (9) Section 66.6 + Terms, conditions, and assurances, Under subsection (a), changes may be made in the use of grant funds by a prantee “only in accordance with procedures established by the Surgeon General." The law provides that the Surgeon General may make a grant only upon recommendation of the National Advisory Council on Regional Medical Programs. We believe that to permit a change in the use of funds without roguirtng an approval of such change by the National Advisory Council would not fulfI the intent of the lnw requiring that the Council pass upon the intended use of these funds. Accordingly, we would recommend that the following sentence be included at the end of subsection (a): Notwithstanding anythiog sontnined in Section $6. 6 to the contrary, such changes in the tne of rrant fonds shall have the approval of the Natlonal Advisory Council on Regional Medien} Progrems, Section 66.7 « Award. Insert, in subsection (a)(), in the second line, before "regional" the word intra, eo that the phrase reads: “through intra-rectonal coopera- . tion"; and also delete the closing phrase "within a geographic area," The original sentence appears to contain either redundant or conflicting phrases, inasmuch as the relation between “regional” and "geographic" is net evident. . Section 66.8 ~ Establishment and operation of regional | medical programs documentary evidence. Strike the word "and" after "Title IX"; insert a eeniicolon after Tithe IX; change the period at the end of the paragraph to & semicolon, and conclude with the following phrase pand (c) the sercoment by rinmbers of the advisory ' group io the recommendstion of satd application. This suggention is made to give effect to the language of the Report of the Committees on Interstate and Foreign Commerce ag follows (p. U): “The coramittee has amended the bill to provide that before any application (10) William B, Stewart, M.D. 9 =5 December 16, 1965 submitted for catablishment and operation of a program in any arca moy be approved by the Surgeon Genoral, ' the local advisory croup must have considered the applie cation and recommended ito approval. " Section 66.9 - Termination. This section authorizes the Surgeon General to revoke or terminate a grant award, in wholo or in part, by a suramary procedure, at any time whenever he finds that in his judgment the grantee hag falicd in a material respect to comply with requixements of Title LX and the regulations of thie port. We believe that thia provision for revocation or termination should provide for a sufficient notice to the grantee and showd include a procedure by which the Advisory Council must concur in this decision. Accord+ inply, we suggest that Section 66.9 be amended by the addition of the following opening phrase; With the gpproval of the Natioual Advisory Council and upon renaronable notices to the sranten, which notice rhall contain the reasonn for the rovecation or terraination, any gran award may be revoked, ete. Section 68.10 « Expenditures by grantee. We would recoramend the following change in subsection (d); ‘Insert in the second Mne after “patients” and before "ig" the following: , to the extent provided tn the stated purposes of Tithe IX, Again, thin change is suggested — #o that patient care ig limited to the extent intended by Congrees, viz., demonstrations in patient care which sre incidental to research and training (including con- tinuing education) activities, We wish to express our appreciation for thig opportunity te review the proposed regulations, We hope that these comments will ' receive your caroful considerstion, . Sincerely, ° .F. 3. l. Blagingame, M. D. ' @@3 Secretary John W. Gardner Philip R. Lee, M.D. James A, Shannon, M.D. : Sinart M_ Keseoms. M.D.